Protocol summary

Summary
This study aimed to evaluate the effect of family-base Psycho-educational on mental health and quality of life of families with bipolar adolescents(12-18 years old) refering hospital affiliated to Shiraz University of Medical Sciences in 2012.This study included 40 family that have bipolar adolescents. Inclusion criteria: no mental illness(according to self-report forms); persons participating in the study have the willing to participate in research; family have adolescents aged 12-18 years old with BD; parents have the lowest literacy through fifth grade; adolescent have not mental retardation, seizure disorder, substance abuse and schizophernia; have signed a written informed consent. Exclusion criteria: unwillingness to participate in the study; lack of coordination of research; failure to participate in more than 2 sessions.The experimental group participated in 6 sessions of Psycho- educational intervention.The control group did not receive any intervention.At the end of the intervention to ethics the control group received an educational pamphelat and this group participated in two sessions.Before,immediately and one month after intervention,Public Health and Quality of life of two groups was measured by General Health Questionnaire and SF36.

General information

Acronym
psycho-educational intervention
IRCT registration information
IRCT registration number: IRCT201304202812N15
Registration date: 2015-07-15, 1394/04/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-15, 1394/04/24
Registrant information
Name
Farkhondeh Sharif
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1212 2401
Email address
fsharif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-01-10, 1392/10/20
Expected recruitment end date
2014-04-04, 1393/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Family-centered Psychoeducation on Mental Health and Quality of life of Families of Adolescents with Bipolar disorder reffered to Medical centers Affiliated to Shiraz University of Medical Sciences.
Public title
Effect of education on family with bipolar adolescent
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: no mental illness(according to self-report forms); persons participating in the study have the willing to participate in research; family have adolescents aged 12-18 years old with BD; parents have the lowest literacy through fifth grade; adolescent have not mental retardation, seizure disorder, substance abuse and schizophernia; have signed a written informed consent. Exclusion criteria: unwillingness to participate in the study; lack of coordination of research; failure to participate in more than 2 sessions.
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

1

Registry name
مركز ثبت كارآزمايي باليني
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Science
Street address
Shiraz,Zand street,University of Medical Science Building
City
Shiraz
Postal code
Approval date
2013-10-06, 1392/07/14
Ethics committee reference number
CT-92-6718

Health conditions studied

1

Description of health condition studied
Bipolar disorder
ICD-10 code
F31.9
ICD-10 code description

Primary outcomes

1

Description
General Health.
Timepoint
Before, immediately, one month after intervention
Method of measurement
General Health questiopnnaire(GHQ28)

Secondary outcomes

1

Description
Quality of life
Timepoint
Before, immediately and one month after intervention
Method of measurement
SF36

Intervention groups

1

Description
Psycho-educational intervention for families in experimental group in 6 sessions .
Category
Prevention

2

Description
The Control group did not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Dr Farkhonde Sharif
Street address
City
Shiraz

2

Recruitment center
Name of recruitment center
Ebne sina Hospital
Full name of responsible person
Dr Farkhonde Sharif
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
shiraz university of medical science
Full name of responsible person
Dr Gholamreza Hatam
Street address
Shiraz university of medical sciences,university central buillding,Beside Red cross,Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shiraz university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Farkhondeh Sharif
Position
Professor
Other areas of specialty/work
Street address
Beside Red cross Building, Zand street
City
Shiraz
Postal code
Phone
+98 71 1823 9725
Fax
Email
fsharif@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Farkhondeh Sharif
Position
Professor
Other areas of specialty/work
Street address
Beside Red cross Building,Zand street
City
Shiraz
Postal code
Phone
+98 71 1823 9725
Fax
Email
fsharif@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Farkhondeh Sharif
Position
Professor
Other areas of specialty/work
Street address
Beside Red cross Building, Zand street
City
Shiraz
Postal code
Phone
+98 71 1823 9725
Fax
Email
fsharif@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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